ACADEMIC RESEARCH ENHANCEMENT AWARD
RELEASE DATE: January 9, 2003
PA NUMBER: PA-03-053 (NOT-OD-06-019 - Notice to clarify that R15 AIDS applications
must use the paper PHS 398 application process for
the January 2, 2006 AIDS submission date.)
(This PA has been reissued, see PA-06-042)
(Change in receipt dates, see NOT-OD-05-080)
APPLICATION RECEIPT DATES: January 25, May 25, September 25
EXPIRATION DATE (Non-AIDS): This PA expired on October 26, 2005 for non-AIDS Applications.
AIDS-RELATED APPLICATION RECEIPT DATES: May 1, September 1, January 2
EXPIRATION DATE (AIDS): This PA expires on January 3, 2006 for AIDS Applications.
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Human Genome Research Institute (NHGRI)
(http://www.nhgri.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
National Library of Medicine (NLM)
(http://www.nlm.nih.gov/)
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov/)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Eligibility Requirements
o Individuals Eligible to Become Principal Investigators
o Mechanism of Support
o Research Objectives
o Application Procedures
o Supplemental Instructions
o Review Considerations
o Award Criteria
o Where to Send Inquiries
o Required Federal Citations
PURPOSE OF THIS PA
The National Institutes of Health (NIH) is continuing to make a special
effort to stimulate research in educational institutions that provide
baccalaureate or advanced training for a significant number of the Nation's
research scientists but that have not been major recipients of NIH support.
Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have
included funds for this initiative, which NIH has implemented through the
Academic Research Enhancement Award (AREA) program. Based on the
expectation that funds will continue to be available each year, the NIH
invites applications for AREA grants (R15) through a standing, an ongoing
Program Announcement (PA).
AREA funds are intended to support new ("type 1") and continuing ("renewal"
or "competing continuation" or "type 2") health-related research projects
proposed by faculty members of eligible schools and components of domestic
institutions. The AREA will enable qualified scientists to receive support
for small-scale research projects. These grants are intended to create a
research opportunity for scientists and institutions otherwise unlikely to
participate extensively in NIH programs to support the Nation's biomedical
and behavioral research effort. It is anticipated that investigators
supported under the AREA program will benefit from the opportunity to conduct
independent research; that the grantee institution will benefit from a
research environment strengthened through AREA grants and furthered by
participation in the diverse extramural programs of the NIH; and that
students will benefit from exposure to and participation in research and be
encouraged to pursue graduate studies in the health sciences.
ELIGIBILITY REQUIREMENTS
Applicant Schools/Components:
All health professional schools/colleges and other academic components of
domestic institutions offering baccalaureate or advanced degrees in the
sciences related to health are eligible, except those that have received
research grants and/or cooperative agreements from the NIH totaling more than
$3 million per year (in both direct and indirect costs) in each of four or
more of the last seven years. Note that this criterion of financial
eligibility is based on the amount of NIH research grant monies received, not
by the institution (university or college) as a whole, but by the individual
school/college or aggregation of "other academic components" (see definition
below) where the principal investigator has an appointment (e.g., School of
Medicine, College of Nursing, etc.). To determine the eligibility of a
school or component with regard to this requirement, applicants should
consult the list of Ineligible schools/components on the AREA Web page at
http://grants.nih.gov/grants/funding/area.htm. If the name of the school
does not appear on the list, it may be eligible to apply for AREA grants.
Applicants should check with their own institutions if unsure.
For purposes of eligibility for the AREA program, the following definitions
apply:
o "Health professional schools" (schools or colleges of medicine, dentistry,
osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry,
allied health, chiropractic, naturopathy and podiatry) means an accredited
public or non-profit private school that provides training leading to a
degree granted by that school (e.g., M.D., D.D.S., M.P.T., D.C., N.D. or
equivalent degree). The term "accredited" means a school or program that is
accredited by a recognized body or bodies approved for such purpose by the
Secretary of Education.
o "Research grants and cooperative agreements" includes all extramural
awards designated by an activity code starting with R, P, M, S, K, or U, and
also G12 and D42. Scientific evaluation awards (R09, U09) are excluded.
o "Other academic components" means all schools, departments, colleges, and
free-standing institutes of the institution EXCEPT the health professional
schools, taken as a SINGLE component.
An applicant school/component may submit several applications proposing
different research projects from different investigators.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
o May not be the principal investigator of any active NIH research grant at
the time of award of an AREA grant (although he or she may be one of the
project personnel for an active NIH grant held by another principal
investigator).
o May not be awarded more than one AREA grant at a time (although he or she
may hold successive AREA grants).
o May not submit an application to NIH for another research project grant
for essentially the same project proposed in a pending AREA application (in
accordance with the general NIH prohibition against the submission in the
same review cycle of more than one application for the same work).
o Is expected to conduct the majority of the research at the grantee
institution, although limited use of special facilities or equipment at
another institution is permitted.
Scientists working in AREA-eligible minority or women's educational
institutions are encouraged to participate in this program.
MECHANISM OF SUPPORT
The R15 mechanism is used to designate applications and awards for AREA
grants, to distinguish the special objectives of these grants from those of
other types of NIH research grants. This award will enable scientists at
eligible institutions to receive support for small research projects, which
might include, feasibility studies, pilot studies, and other small-scale
research programs. Through this mechanism, a maximum of $150,000 in direct
costs plus facilities and administrative (formerly, indirect) costs at the
rate negotiated for the institution may be awarded for a period of up to
three years. Allowable direct costs include salaries for the principal
investigator and other research personnel (including students), supplies,
equipment, travel, and other items specifically associated with the proposed
research project.
Supplemental Funding of Existing Grants
For Underrepresented Minority Students: The NIH recognizes the need to
increase the number of underrepresented minority scientists participating in
biomedical and behavioral research. Therefore, it is emphasizing the use of
administrative supplements to existing grants in order to attract
underrepresented minorities into biomedical and behavioral research.
Principal investigators at domestic institutions who hold an active NIH
research grant (including an active AREA grant) are eligible to submit a
request for an administrative supplement to the awarding component that
issued the parent grant. For the purposes of an active AREA grant, the
request will be to support a minority candidate who is a high school or
undergraduate student. Exceptions to this rule may be made by the awarding
component that issued the AREA grant. For a full discussion of this
additional funding opportunity and procedures for submitting a request for a
supplement, see the NIH Guide for Grants and Contracts, April 9, 2001 at the
following Web site: http://grants.nih.gov/grants/guide/pa-files/PA-01-079.html
For Individuals with Disabilities: The NIH also recognizes the need to
extend opportunities to individuals with disabilities who are capable of
entering or resuming research careers. According to the Americans With
Disabilities Act, a "disabled individual" is one who has a physical or mental
impairment that substantially limits one or more major life activities, who
has a record of such impairment, or who is regarded as having such an
impairment.
Accordingly, principal investigators of an active AREA grant may also submit
a request for an administrative supplement for this purpose to the awarding
component that issued the parent grant. For a full discussion of this
additional funding opportunity and procedures for submitting a request for a
supplement, see the NIH Guide for Grants and Contracts, April 9, 2001 at the
following Web site:
http://grants.nih.gov/grants/guide/pa-files/PA-01-080.html
RESEARCH OBJECTIVES
Background
The NIH is the principal research arm of the Department of Health and Human
Services (HHS). At present, 24 awarding components (known as Institutes or
Centers) and several support and service Centers constitute the NIH. The NIH
fosters the development of new knowledge in the biomedical and behavioral
sciences, the ultimate goal of which is to combat disease and improve the
health of mankind. To achieve its goals, the NIH conducts research in its
own laboratories and clinics, and it funds research conducted in research and
academic institutions throughout the world by means of grants, cooperative
agreements, and contracts. The majority of grantees are academic
institutions, but other organizations (including for-profit organizations)
participate significantly in NIH-supported research. The NIH provides funds
for research projects, research training, career development of new and
established scientists, and research and medical library resources.
Research grants represent the largest proportion of all NIH extramural
awards. The research plan for each research grant application is generated
and developed by an investigator referred to as the "principal investigator."
On behalf of the investigator, the institution submits the grant application
to the NIH for consideration for support. Principal investigators of NIH
grant applications are most frequently affiliated with universities or
medical and dental schools, and most hold doctorate degrees. Requirements
for who may be a principal investigator on an application (e.g., tenure-track
status, citizenship status, etc.) are those of the institution, not NIH.
The NIH has long used a dual peer review system for the evaluation of
applications. This system, which has a statutory base, ensures that only the
most meritorious and relevant proposals are considered for funding. The
first level of review involves panels composed primarily of non-Federal
experts, referred to as Scientific Review Groups (SRGs) or "study sections"
that are organized according to scientific areas. These panels of experts
render an impartial review and evaluation of each application. They consider
not only the scientific merit of a proposal, but also the background and
experience of the principal investigator, the research facilities available
for the project, and the appropriateness of the direct costs requested.
The second level of review is conducted by the National Advisory Council or
Board of the awarding component to which the application is assigned. These
groups, composed of scientists, physicians, dentists, and laypersons who are
leaders in public affairs, are chosen for their expertise, interest, or
activity related to the awarding component's mission. The council or board
will take into account the relevance of the goals of the project in relation
to the mission of the awarding component, program balance, and the
availability of funds. The Center for Scientific Review (CSR), a component of
the NIH, receives all grant applications submitted to the NIH, assesses each
one for relevance to the health mission of the NIH; and assigns those that
are acceptable to the appropriate Scientific Review Group (SRG) for initial
scientific merit review, and to the appropriate NIH awarding component for
consideration for an award.
The AREA program and its application, review, and award procedures have been
developed within this established framework for NIH grant-supported research
activities.
Research Objectives of the NIH Institutes and Centers
AREA grants will support small-scale, new or ongoing health-related
meritorious research projects, including pilot research projects and
feasibility studies; development, testing, and refinement of research
techniques; secondary analysis of available data sets; and similar discrete
research projects that demonstrate research capability. Listed below, by
Institute or Center, are the research topics of particular interest to the
Institute/Center under the AREA program. Listed in the INQUIRIES section is
the AREA program representative for each of the participating Institutes and
Centers. A potential applicant is encouraged to contact the person listed
for the particular Institute(s) or Center(s) with research interests relevant
to the applicant's proposed topic for additional scientific program
information and for pre-application guidance.
The research objectives of the AREA program are those of the individual NIH
Institutes and Centers, as follows:
National Institute on Aging (NIA or AG)
The NIA is interested in, and has responsibilities for, aging research that
includes fundamental studies of biological processes, including studies of
aging at the molecular, genetic, organelle, cellular, organ, and organ system
levels; the interaction of aging and diseases of aging; biomedical and
psychosocial factors in maintaining health and effective functioning in the
middle and later years, relevant social and behavioral relationships; and
research that broadens the base of knowledge underlying adequate health
services for the aging and the aged. The Institute is interested in normal
physiological and biochemical changes with aging, involving areas such as
immunology, cognition, neurobiology, endocrinology, nutrition, and exercise
physiology, as well as clinical diseases and disorders of aging such as
Alzheimer's disease, impaired sleep, sensory and motor disorders,
osteoporosis, osteoarthritis, falls, and urinary incontinence. The Institute
also has responsibility for research concerned with the biological, social,
psychological, cultural, epidemiological, demographic and economic factors
that affect both the process of growing old and the status and roles of older
people in society. Under this broad mandate, health and wellbeing are viewed
as the outcome of complex biological, physiological, medical, psychological,
and socioenvironmental processes.
National Institute on Alcohol Abuse and Alcoholism (NIAAA or AA)
The NIAAA supports basic and clinical research to develop new knowledge in a
wide range of areas relevant to alcohol abuse problems and alcohol addiction.
Areas of research include molecular, physiological, and behavioral mechanisms
leading to pathological drinking behavior and alcohol-induced organ damage;
identification of genes and gene-environment interactions that contribute to
susceptibility; health services and outcomes research; and clinical,
behavioral, and epidemiological studies that will lead to more effective
diagnosis, prevention, and treatment of alcohol use disorders and associated
alcohol-related medical conditions. Basic and clinical research on fetal
alcohol spectrum disorders is also supported. The NIAAA encourages alcohol-
relevant research in any of the basic science disciplines, epidemiology,
social and behavioral sciences, computer modeling, and health economics.
National Institute of Allergy and Infectious Diseases (NIAID or AI)
The objective of NIAIID's research program is to acquire the knowledge which
will eventually lead to the treatment and prevention of infectious, allergic,
and immunologic diseases. The Institute's overall strategy of attacking the
array of problems on a broad front relies on free-ranging research in
microbiology and includes the following research problem areas: isolation,
characterization, and biology of disease-causing microbes; antibiotic or drug
resistance among bacteria, viruses, and parasites; development of successful
and safe antimicrobial compounds, particularly for viruses and parasites; and
new approaches to understand and manipulate the immune system.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS
or AR)
The NIAMS supports basic and clinical studies related to the rheumatic
diseases and to diseases and disorders of connective tissue, bone, and skin.
Areas of research include: inflammation, infectious agents and genetic
factors related to rheumatic diseases; structure and function of cartilage
and connective tissue; arthritis in children; systemic lupus erythematosus;
rheumatoid arthritis; - osteoarthritis; spondylitis and related syndromes;
gout and pseudogout; the structure and function of skeletal muscle; bone
structure, formation, degradation and repair; osteoporosis; biomaterials,
biomechanics, and joint replacement; inherited connective tissue diseases;
bone immunology and transplantation; metabolism of epidermis, dermis and
subcutaneous fat; immunologically mediated cutaneous disorders; photobiology,
photoallergy, and phototoxic reactions; vitiligo; psoriasis, bullous diseases
of the skin; and acne.
National Institute of Biomedical Imaging and Bioengineering (NIBIB or EB)
The mission of the NIBIB is to improve health by promoting fundamental
discoveries, design and development, and translation and assessment of
technological capabilities in biomedical imaging and bioengineering, enabled
by relevant areas of physics, chemistry, mathematics, materials science,
information science, and the computer sciences. The Institute plans,
conducts, fosters, and supports an integrated and coordinated program of
research and research training that can be applied to a broad spectrum of
biological processes, disorders and diseases, and organ systems. The
Institute coordinates with the biomedical imaging and bioengineering programs
of other agencies and NIH institutes to support imaging and engineering
research with potential medical applications and facilitates the transfer of
such technologies to medical applications.
The Institute supports hypothesis-, design-, technology- or problem-driven
research relating to the discovery, design, development, translation and
assessment of new knowledge in biomedical imaging and bioengineering. This
research may utilize, for example, an organ or disease as a model system for
development purposes. The research should be assigned to another Institute
or Center if it is primarily applicable to an organ, disease or mission of
that entity. Alternatively, several Institutes or Centers may collaborate on
research of mutual interest.
National Cancer Institute (NCI or CA)
The NCI is the Federal Government's principal agency for cancer research and
control. Programs of the NCI focus on: (1) cancer etiology including
laboratory, field, and epidemiologic and biometric research on the cause and
natural history of cancer and means for preventing cancer, as well as studies
on the mechanisms of cancer induction and promotion by chemicals, viruses,
and environmental agents; (2) cancer biology and diagnosis research in the
areas of cell biology, immunology, molecular biology, developmental biology,
biochemistry, genetics, and pathology; (3) cancer metastasis research in the
areas of invasion, cell migration, progression and metastasis, and the
studies focusing on tumor-host interactions; (4) cancer treatment research in
the areas of drug development, biological response modifiers, and
radiotherapy development, including diagnostic imaging and clinical trials
for curing or controlling cancer; (5) early detection and diagnosis research,
including studies of promising biomarkers; and (6) cancer prevention and
control research, development, technology transfer, demonstration, and
education and information dissemination programs to expedite the use of new
information relevant to prevention, detection, and diagnosis of cancer and
pretreatment evaluation, treatment, rehabilitation, and continuing care of
cancer patients.
National Institute of Child Health and Human Development (NICHD or HD)
The goal of NICHD's research programs is the improvement of maternal, infant,
and child health through support of basic and clinical research to elucidate
normal and abnormal growth, development, and maturation, from gametogenesis
through maturity. To this end, NICHD supports research in: reproductive
biology, chemistry, and medicine; fertility regulation; contraceptive
development and evaluation; perinatology, pregnancy, and labor; developmental
and clinical genetics; developmental biology; developmental neurobiology;
developmental and reproductive immunology; birth defects; population
dynamics; developmental endocrinology; social, cognitive, and affective
development; and the biological bases of behavioral development.
The NICHD also supports biomedical and behavioral research on mental
retardation and developmental disabilities; pediatric, adolescent, and
maternal HIV infection and AIDS; and, in the context of its National Center
for Medical Rehabilitation Research, NICHD also supports the development of
medical, behavioral, psychological, social, and technological interventions
designed to optimize functioning after impairment, disability, or handicap.
National Center for Complementary and Alternative Medicine (NCCAM or AT)
The National Center for Complementary and Alternative Medicine (NCCAM)
explores complementary and alternative healing practices in the context of
rigorous science; it educates and trains complementary and alternative
medicine (CAM) researchers; and disseminates authoritative information to the
public and professionals. CAM encompasses healthcare and medical practices
that are not currently an integral part of conventional medicine. The list
of CAM approaches evolves steadily as some are proven safe and effective and
accepted within "mainstream" healthcare practices while others are rejected
as being unsafe or ineffective. CAM practices are grouped within five major
domains: (1) alternative medical systems (for example, Traditional Chinese
Medicine, Ayurveda; (2) mind-body interventions, (for example, meditation,
biofeedback); (3) biologically-based treatments (for example, herbal
therapies, special diets); (4) manipulative and body-based methods (for
example, chiropractic, massage); and (5) energy therapies (for example,
Reiki, Qi gong). (Further examples of practices within each CAM domain can be
viewed at http://nccam.nih.gov/health/whatiscam/index.htm)
In order to meet this mandate, NCCAM supports research and research training
programs that increase our knowledge of basic mechanisms underlying CAM
approaches, and of their safety and efficacy. Studies may range from basic,
through translational, clinical, epidemiological and health services.
National Institute on Deafness and Other Communication Disorders (NIDCD or DC)
The NIDCD supports biomedical and behavioral research related to the normal
and disordered processes of hearing, balance, smell, taste, voice, speech and
language. Basic and clinical studies are encouraged of genetic, molecular,
cellular, physiological, biochemical, and behavioral aspects of function in
health and disease. The Institute also supports research concerned with
disease prevention, health promotion and the special biomedical and
behavioral problems associated with communication impairments and disorders.
National Institute of Dental and Craniofacial Research (NIDCR or DE)
The mission of the NIDCR is to promote the dental, oral and craniofacial
health of the American people through the conduct and support of research and
the training of researchers. This includes the support of basic, clinical,
and behavioral research concerning the etiology, epidemiology, prevention,
diagnosis, and treatment of dental, oral and craniofacial disorders and
diseases. In this context, the NIDCR emphasizes research on caries and
periodontal diseases; oral viral infections; oral aspects of AIDS/HIV
infection; head and neck cancers; craniofacial development, physiology and
malformations; orofacial pain and other oral sensory and motor dysfunctions;
salivary glands and disorders such as Sjogrens's Syndrome; temporomandibular
joint disorders; and restoration and regeneration of dental, oral and
craniofacial structures.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK or
DK)
The NIDDK supports a broad range of fundamental and clinical investigation
related to numerous diseases affecting the public health, including diabetes;
obesity; endocrinology and endocrine disorders including osteoporosis;
kidney, urologic and blood diseases; and digestive and liver diseases and
nutrition. These include genetic diseases such as cystic fibrosis, polycystic
kidney disease and inborn errors of metabolism; autoimmune diseases such as
type 1 diabetes and inflammatory bowel disease; and infectious diseases such
as hepatitis and food borne illness.
National Institute on Drug Abuse (NIDA or DA)
The research programs of the NIDA are devoted to increasing the understanding
of the causes, progression and consequences of drug abuse, as well as to
developing effective prevention and treatments. Research is supported on the
complex neurobiological, behavioral, clinical, social and environmental
components of drug abuse and addiction. In addition, NIDA supports research
on mechanisms, processes, and problems (e.g., studies of cognitive processes
and general addictive processes) that may ultimately contribute to the
understanding of drug abuse and addiction, although it does not involve
examination of an abused drug or use of a drug-abusing sample. Studies of
HIV/AIDS, HCV and other STDs and drug abuse are also of interest. Drugs
studied in NIDA-supported projects include psychomotor stimulants (cocaine,
methamphetamine), opiates/opioids, hallucinogens, designer drugs,
marijuana/cannabinoids, nicotine and other tobacco components, inhalants,
abused prescription drugs, and over-the-counter products. Research involves
basic and clinical neurobiology, molecular and cellular biology, chemistry,
pharmacology, genetics, immunology, epidemiology, medication development,
behavioral treatment, and behavioral sciences, as well as disciplines in
clinical research, social and community research, health services, and
prevention interventions. NIDA also supports science education research
projects.
National Institute of Environmental Health Sciences (NIEHS or ES)
Human health and human disease result from three interactive elements:
environmental factors, genetic susceptibility, and age. The mission of the
National Institute of Environmental Health Sciences (NIEHS) is to reduce the
burden of human illness and dysfunction from environmental causes by further
understanding each of these elements and how they interrelate. Environmental
health comprises those aspects of human health, including quality of life,
that are determined by physical, chemical, biological, social and
psychosocial factors in the environment. Elements within the latter
categories include socioeconomic status, education, and cultural variables,
which can be considered as both individual and community-level influences.
The Institute supports research and training focused on identification,
assessment, and mechanism of action of potentially harmful agents in the
environment. Research results form the basis for preventative programs for
environmentally-related diseases and for action by regulatory agencies. The
NIEHS, thus, has responsibility for providing knowledge to assist in societal
decisions related to the impact of physical and social exposures on human
health. This responsibility mandates efforts toward a thorough understanding
of the early manifestations and mechanisms of human disease due to exposure
to hazardous environmental conditions, development of more accurate and rapid
methods to predict and assess toxicity, enhancement of prevention and
intervention strategies, and translation of research findings into
information that can be used to improve public health.
National Eye Institute (NEI or EY)
The mission of the NEI is to gain new knowledge concerning the eye and visual
system in health and disease. The NEI supports research and research
training aimed at developing a more complete understanding of normal tissue
and normal visual processes so that a more complete understanding may be
gained of the abnormal processes that lead to diseases of the eye and
disorders of vision. The major objectives of NEI-supported research are to
discover the most appropriate and effective means to prevent, treat, and
rehabilitate visual disorders, and to determine the best means to disseminate
timely research findings and information that will promote visual health.
Both basic and clinical research are funded under the following major NEI
programs: Retinal Diseases; Corneal Diseases; Lens and Cataract; Glaucoma;
Strabismus, Amblyopia, and Visual Processing; and Low Vision and Its
Rehabilitation. Within each program, research ranges from attempts to
elucidate the fundamental biological processes that underlie disease to the
development and clinical testing of new diagnostic and therapeutic
techniques.
National Institute of General Medical Sciences (NIGMS or GM)
The mission of the National Institute of General Medical Sciences is to support
basic, biomedical research that contributes to fundamental cellular and
physiological principles. General areas of interest include cell biology,
biophysics, structural genomics, proteomics, bioinformatics, genetic
mechanisms, developmental biology, chemistry, biochemistry, physiology, trauma
and burn, anesthesiology, and pharmacology. The molecular, genetic,
functional, and structural understanding of biological molecules, their
interactions and their organization, as well as the discovery of approaches to
their control will contribute to understanding mechanisms for a variety of
diseases. NIGMS also supports research in the fields of mathematics, physics,
computer science, and engineering that are applicable to its mission.
National Heart, Lung, and Blood Institute (NHLBI or HL)
The NHLBI supports basic and clinical research pertaining to the structure,
function, and diseases of the cardiovascular system, lungs, blood and blood
vessels, and sleep disorders. The Institute's also supports research in stem
cell biology and transplantation, transfusion medicine, and blood resources.
The NHLBI carries out its mission through a number of research programs that
provide support for projects ranging from studies at the molecular level to
whole body studies in man and animals. Examples of research areas supported
by the Institute include atherosclerosis, hypertension, cerebrovascular
disease (directed at the dependent variable of blood, heart, or blood
vessel), coronary heart disease, peripheral vascular diseases, arrhythmias,
heart failure, and shock, congenital and rheumatic heart diseases,
cardiomyopathies and infections of the heart, circulatory assistance, lung
cell and molecular biology, chronic obstructive lung diseases, pediatric
pulmonary diseases, cystic fibrosis, sleep-disordered breathing, asthma,
fibrotic and immunologic lung diseases, acute respiratory failure, pulmonary
vascular diseases, HIV-associated lung disorders and bone marrow suppression,
bleeding and clotting disorders, disorders of the red blood cell such as
sickle cell disease and Cooley's anemia, bone marrow failure syndromes, and
blood resources.
National Human Genome Research Institute (NHGRI or HG)
The NCHGR is currently engaged in a research program designed to characterize
the human genome and the genomes of selected model organisms. This research
program has the following interrelated goals: the construction of high
resolution genetic linkage maps; the development of a variety of physical
maps; the determination of the complete nucleotide sequence of the DNA of
selected organisms; the development of the capability for collecting,
storing, distributing, and analyzing the data produced; and the development
of appropriate new technologies to achieve these goals. This project will
develop a series of resources that will be available to the research
community to facilitate both basic research and the application of the
knowledge gained to the prevention, diagnosis, and therapy of disease.
National Institute of Mental Health (NIMH or MH)
The goal of the NIMH is to reduce the burden of mental and behavioral
disorders through research on mind, brain, and behavior. To this end, the
NIMH supports and conducts research into the fundamental processes of brain
and behavior, translational studies linking basic neuroscience discoveries to
mental disorders, intervention studies, and investigations to improve the
delivery of mental health services in diverse settings. The NIMH is also
committed to supporting research to prevent the spread of HIV/AIDS and reduce
the burden of illness in infected individuals through behavioral
interventions, and to understand, prevent, and treat the consequences of HIV
disease of the CNS.
National Institute of Neurological Disorders and Stroke (NINDS or NS)
The NINDS supports basic, translational and clinical research on healthy and
diseased brains, spinal cord and peripheral nerves. Examples of specific
research areas supported by NINDS include: development, neurotrophic factors,
cognition, epilepsy, stroke, cerebrovascular disorders, neuropathic pain,
traumatic brain and spinal cord injury, Parkinson's disease, Alzheimer's
disease, Huntington's disease, multiple sclerosis, muscular dystrophy and
other neuromuscular disorders, brain tumors, autism, and genetic disorders of
the nervous system.
National Institute of Nursing Research (NINR or NR)
The mission of the National Institute of Nursing Research is to support
clinical and basic research to establish a scientific basis for the care of
individuals across the life span-from management of patients during illness
and recovery to the reduction of risks for disease and disability, the
promotion of healthy lifestyles, the improvement of quality of life in those
with chronic illness, and care for individuals at the end of life. This
research may also include families within a community context. According to
its broad mandate, the Institute seeks to understand and ease the symptoms of
acute and chronic illness, to prevent or delay the onset of disease or
disability or slow its progression, to find effective approaches to achieving
and sustaining good health, and to improve the clinical settings in which
care is provided. Nursing research involves clinical care in a variety of
settings including the community and home in addition to more traditional
health care sites. The NINR's research extends to problems encountered by
patients, families, and caregivers. It also focuses on the special needs of
at-risk and under-served populations, with an emphasis on health disparities.
In order to meet the mission of the NINR, AREA applicants are invited to
submit applications related to 8 broad areas of research interest including:
chronic illness experiences, cultural and ethnic considerations in health and
illness, end of life/palliative care, health promotion and disease
prevention, implications of genetic advances, quality of life and quality of
care, symptom management of illness and treatment, and telehealth
interventions and monitoring.
National Library of Medicine (NLM or LM)
The objective of NLM's research program is the support of investigations
related to the generation, organization, and utilization of health knowledge.
Such support may involve: (1) medical informatics research, a branch of
investigation of the fundamental issues of health knowledge communication
vis-a-vis advanced computer technologies; (2) research in health science
librarianship and information science; or (3) assistance for the preparation
and publication of scientific works in the health area.
National Center for Research Resources (NCRR or RR)
The NCRR administers programs that develop and ensure the availability of
resources essential to the efficient and effective conduct of human health-
related research. NCRR programs are primarily institutional in nature but,
while support is generally in the form of resource grants, the NCRR makes
awards for support of projects which contribute to improvement of the
capability of resources to serve biomedical research. The following are
research areas appropriate to the NCRR interests: (1) Research and
Development in Instrumentation and Specialized Technologies for Biomedical
Research. This encompasses instruments, devices, and processes to facilitate
research in blomolecular and cellular structure and function.
(Instrumentation includes mass spectrometry, nuclear magnetic resonance,
electron spin resonance, equipment for fast kinetic research, X-ray
diffraction, electron microscopy, and flow cytometry.) The application of
computer science, computer engineering, and biomedical engineering to
biomedical research problems is also of interest. (This includes knowledge
engineering, information technology, computer graphics, image processing,
computer modeling and simulation, task dedicated computer systems, and
development of implantable microsensors and transducers.); (2) Research in
Laboratory Animal Sciences. (This includes the etiology, pathogenesis, and
control of laboratory animal diseases, as well as the environmental
requirements of laboratory animals.); and (3) Development of Biomedical
Research Methods Employing Lower Organisms, Tissues/Cells in Culture, or
Mathematical and Computer Simulations.
APPLICATION PROCEDURES
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, telephone (301) 435-0714,
email: GrantsInfo@nih.gov.
Applicants should use the PHS 398 with the AREA guidelines. See
http://grants.nih.gov/grants/funding/area.htm. The PHS 398 contains
instructions on submission procedures that must be observed by AREA
applicants. These instructions must be adhered to, except where they have
been modified by the following Supplemental Instructions.
SUPPLEMENTAL INSTRUCTIONS
As AREA applications are one of the mechanisms included in NIH's Modular
Grants initiative, applicants must observe the supplemental instructions for
modular grant applications contained in the Notice published in the NIH Guide
for Grants and Contracts on December 18, 1998
(http://grants.nih.gov/grants/guide/notice-files/not98-178.html). Briefly,
the features of modular grants related to application preparation include:
the requirement that direct costs be requested only in modules of $25,000,
the omission of information on detailed budget categories and on pending
"Other Support," and the inclusion in the "Biographical Sketch" of
information on related research projects in which key personnel are currently
participating or have participated.
The specific instructions below refer to those items in the PHS 398
application form where the information requested, following from the Modular
Grant initiative or the AREA program requirements, either has been modified
or should not be provided at submission although the information may be
requested after initial review by the NIH awarding component if there is a
likelihood that the application will be funded.
PHS 398
o FACE PAGE:
Item 2 -- Check the "YES" box and enter "Academic Research Enhancement Award"
as the title. The PA number should be entered.
Item 6 --The entire proposed project period must not exceed three years.
Items 7a and 7b should be completed, indicating Direct Costs (in $25,000
increments up to a maximum of $150,000) and Total Costs [Modular Total Direct
plus Facilities and Administrative (F&A) costs] for the entire budget period.
Items 8a and 8b, which are identical to Items 7a and 7b, respectively, in
AREA applications, should be completed indicating the Direct and Total Costs
for the entire proposed period of support. AREA grants are multiyear funded,
therefore the requested budget period and total project period must be
identical.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form page.
o Under Personnel, list all project personnel, including their names,
percent of effort, and roles on the project. No individual salary information
should be provided. However, the applicant should use the NIH appropriation
language salary cap and, if appropriate, the NIH policy for graduate student
compensation in developing the budget request.
o The students who will be involved in the research should be included here.
If they have not yet been individually identified, the number and academic
level of those to be involved should be provided. Since a primary objective
of the AREA program is to support investigators doing meritorious research at
non-research intensive and/or undergraduate institutions, principal
investigators are encouraged to include students in the proposed research to
the extent practicable.
- If there are any Consultants for the project, provide their names,
organizational affiliations, and the services they will perform.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount,
which is a maximum of $150,000. Include the Letter of Intent to establish a
consortium.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, including collaborators, following the instructions below.
No more than four pages may be used for each person. A sample biographical
sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.
For the principal investigator only, provide information on his or her: (a)
previous or current experience in supervising students in research, and/or
(b) other relationships within the institutional framework (e.g., cross-
departmental research collaborations.
OTHER SUPPORT
Do not submit this page. However, the Biographical Sketch for each of the
key personnel should include information on the other projects that the
person is working on or has worked on that are relevant to the proposed
project (see above).
RESOURCES
In addition to the information requested on the Form, under "Other," provide
the following information:
o a profile of the students of the applicant school/academic component and
any information or estimate of the number who have obtained the baccalaureate
degree and gone on to obtain an academic or professional doctoral degree in
the health-related sciences during the last five years;
o a description of the special characteristics of the school/academic
component that make it appropriate for an AREA award, where the goals of the
AREA program are to: (1) strengthen the research environment of schools that
are not research intensive; (2) expose students in such environments to
research, and (3) provide support for meritorious research.
o a description of the likely impact of an AREA award on the principal
investigator and the school/academic component. How will the AREA award
strengthen the research environment of the school/academic component? How
will the AREA award expose students to research?
o a statement of institutional support for the proposed research project
(e.g., release time, other support, matching funds, etc.).
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F&A costs.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.
PERSONNEL REPORT
Do not submit this page. Instead, this information should be provided in the
Narrative Budget Justification (see above).
REVIEW CONSIDERATIONS
AREA applications are reviewed by scientific review groups administered by
the NIH Center for Scientific Review (CSR) and are evaluated for scientific
and technical merit according to standard NIH peer review procedures, as
described above (see Background). Applications will be assigned on the basis
of established Public Health Service referral guidelines. As part of the
initial merit review, a streamlined review process, which is employed for the
review of most NIH research grant applications, may be used. Under this
process, reviewers are asked to identify the upper half of applications.
These applications are discussed at the review group meeting and receive a
priority score ranging from "best" (100) to "average" (300), while the lower
half of applications are normally not discussed nor given a priority score.
Nevertheless, all applicants will receive a summary statement, which will
consist of the written critiques of two or more of the reviewers
participating in the review group meeting.
The review schedule that will apply to AREA grant applications is as follows:
Cycle I Cycle II Cycle III
Postmark Dates for:
- All Other AREA Applications: Jan 25 May 25 Sep 25
- AIDS-Related Applications: May 1 Sep 1 Jan 2
Scientific Merit Review: Jun/Jul Oct/Nov Feb/Mar
Advisory Council Review: Sep/Oct Jan/Feb May/Jun
Earliest Project Start Date: Dec April July
Review Criteria: In carrying out the scientific and technical merit review
of AREA applications, the scientific review group will base its
recommendation and score (if the application is scored) on the overall impact
of the application on its field of study by considering the following review
criteria:
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
Is the applicant school/academic component suitable for an award in terms of
strengthening the research environment.
In addition, all applications will be evaluated with respect to the
appropriateness of the budget, the inclusion of children, minorities, and
women in clinical research projects, the procedures for the protection of
animal or human subjects, and the adequacy of protections for research
personnel from biohazards. Further information about these considerations is
available at: http://www.csr.nih.gov/guidelines/proc.htm.
AWARD CRITERIA
AREA grants are awarded on a competitive basis. Funding decisions on
individual applications will be based on the proposed research project's
scientific merit as evaluated in the initial scientific merit review and its
relevance to NIH programs, and on the applicant institution's contribution to
the undergraduate preparation of doctoral-level health professionals. Thus,
after the initial scientific-technical review, applications receive a second-
level review by the National Advisory Council of the Institute or Center to
which the application has been assigned for potential funding. In
conformance with the spirit of the House Committee Report 98-911 (to
accompany H.R. 6028, HHS Appropriations for FY 1985), special consideration
will be given in the funding decision process to applications from those
"smaller, less prominent, four-year, public and private colleges and
universities which provide undergraduate training for a significant number of
our nation's research scientists but which have not shared adequately in the
growth of the NIH extramural program."
Both annual Progress Reports and a Final Progress Report will be required of
all AREA grantees.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. For inquiries of a scientific
nature, potential applicants should contact the Program Contact persons for
the Institutes whose scientific interests most closely match those of the
proposed research (see Research Objectives section above). The Program
Contacts for the Institutes and Centers are:
National Institute on Aging
Dr. Miriam Kelty
Associate Director, Office of Extramural Affairs
7201 Wisconsin Avenue, Room 2C218
Bethesda, MD 20892-9205
Phone: (301) 496-9322
FAX: (301) 402-2945
E-mail: mk46u@nih.gov
National Institute on Alcohol Abuse and Alcoholism
Dr. Laurie Foudin
Division of Basic Research
6000 Executive Boulevard, Suite 402
Bethesda, MD 20892-7003
Phone: (301) 443-0912
Fax: (301) 594-0673
E-mail: lf29z@nih.gov
National Institute on Allergy and Infectious Diseases
Mr. Al Czarra
Director, Office of Program Coordination and Operations
Division of Extramural Activities
Solar Building, Room 3C28
Bethesda, MD 20892
Phone: (301) 496-7291
Fax: (301) 402-0369
E-mail: ac20a@nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Dr. Steven J. Hausman
Deputy Director
Building 31, Room 4C32
Bethesda, MD 20892-2350
Phone: (301) 402-1691
Fax: (301) 480-6069
E-mail: sh4lg@nih.gov
National Institute of Biomedical Imaging and Bioengineering
Dr. Grace C. Y. Peng
Program Director
6707 Democracy Blvd., Room 226, MSC 5469
Bethesda, MD 20892-5469
Phone: (301) 496-9178
Fax: (301) 480-0679
E-mail: penggr@mail.nih.gov
National Cancer Institute
Dr. Christopher L. Hatch
Chief, Program Coordination and Referral Branch
6116 Executive Blvd., Room 8047
Bethesda, MD 20892-8329
Rockville, MD 20852 (for courier/express delivery)
Phone: (301) 496-3428 Fax: (301) 402-0275
E-mail: ncirefof@dea.nci.nih.gov
National Institute of Child Health and Human Development
Michael Whalin, Ph.D.
Office of Extramural Policy
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4A05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6888
Email: whalinm@mail.nih.gov
National Center for Complementary and Alternative Medicine
Dr. Neal B. West
Program Officer
Two Democracy Plaza, Suite 401
Phone: (301) 402-5867
Fax: (301) 480-3621
E-mail: westn@mail.nih.gov
National Institute on Deafness and Other Communication Disorders
Barry J. Davis, Ph.D.
Scientific Programs Branch
Division of Extramural Research
EPS-400D MSC 7180
6120 Executive Blvd.
Rockville, MD 20892-7180
Phone: 301-402-3464
FAX: 301-402-6251
E-mail: Barry_Davis@nih.gov
National Institute of Dental and Craniofacial Research
Dr. Dennis F. Mangan
Referral Liaison
Building 45, Room 4AN-18
Bethesda, MD 20892-6402
Phone: (301) 594-2421
Fax: (301) 480-8319
E-mail: dennis.Mangan@nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases
Dr. Robert Hammond
Director, Division of Extramural Activities
Two Democracy Plaza, Room 715
6707 Democracy Blvd.
Bethesda, MD 20892-5456
Phone: (301) 594-8834
Fax: (301) 480-4125
E-mail: rh247f@nih.gov
National Institute on Drug Abuse
Dr. Teresa Levitin
Director, Office of Extramural
6001 Executive Blvd., Room 3158
Bethesda, MD 20892-9547
Phone: (301) 443-2755
Fax: (301) 443-0538
E-mail: tl25u@nih.gov
National Institute of Environmental Health Sciences
Dr. Jerrold Heindel
P.O. Box 12233, North Campus MD 3-03
Research Triangle Park, NC 27709
Phone: (919) 541-0781
Fax: (919) 541-2843
E-mail: heindelj@niehs.nih.gov
National Eye Institute
Dr. Ralph J. Helmsen
Research Resources Officer
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
Phone: (301) 451-2020
Fax: (301) 402-0528
E-mail: rh27v@nih.gov
National Institute of General Medical Sciences
Dr. Jean Chin
Program Director
Building 45, Room 2AS.19A
Bethesda, MD 20892-6200
Phone: (301) 594-2485
Fax: (301) 480-2004
E-mail: chinj@nigms.nih.gov
National Heart, Lung, and Blood Institute
Dr. Helena O. Mishoe
Office of Minority Health Affairs
6701 Rockledge Drive, Room 6218
Bethesda, MD 20892-7913
Phone: (301) 451-5081
Fax: (301) 480-0862
E-mail: hm31y@nih.gov
National Human Genome Research Institute
Dr. Bettie J. Graham
Chief, Research Grants Branch
Building 38A, Room 610
Bethesda, MD 20894
Phone: (301) 496-7531
Fax: (301) 480-2770
E-mail: bg30t@nih:gov
National Institute of Mental Health
Dr. Jean G. Noronha
NIMH Referral Liaison
6001 Executive Boulevard, Room 6154 MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
E-mail: jnoronha@nih.gov
National Institute of Neurological Diseases and Stroke
Dr. Randall R. Stewart
NINDS AREA Grant Coordinator
Neuroscience Center, Room 2135
6001 Executive Boulevard
Bethesda, MD 20892-9523
Phone: (301) 496-6460
Fax: (301) 402-1501
E-mail: stewartr@ninds.nih.gov
National Institute of Nursing Research
Dr. Hilary Sigmon
Program Director
Office of Extramural Programs
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870
Phone: (301) 594-5970
Fax: (301) 480-8260
E-mail: hilary.sigmon@nih.gov
National Library of Medicine
Dr. Milton Corn
Division of Extramural Programs
Building 38A, Room 5N505
Bethesda, MD 20894
Phone: (301) 496-4621
Fax: (301) 402-0421
E-mail: rd57e@nih.gov
National Center for Research Resources
Dr. Louise E. Ramm
Deputy Director
Building 12A, Room 4009
Bethesda, MD 20892-5662
Phone: (301) 496-6023
Fax: (301) 402-0006
E-mail: lr34m@nih.gov
Questions regarding eligibility, policies, procedures, and other
administrative aspects of the NIH AREA program should be referred first to
the Office of Sponsored Programs at the educational institution. Issues that
remain after consultation with the institutional Office of Sponsored Programs
and that are not addressed in these AREA Program Guidelines may be directed
to:
Linda Stecklein
NIH AREA Coordinator
Office of Extramural Research
National Institutes of Health
6705 Rockledge Drive, Room 3524
Bethesda, MD 20892
Phone: (301) 402-7989
Fax: (301) 435-3059
E-mail: stecklel@od.nih.gov
These Program Guidelines and other information related to the AREA program
are available on the AREA Web page at:
http://grants.nih.gov/grants/funding/area.htm
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC):
Criteria for federal funding of research on hESCs can be found at
http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding
(see http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in the
proposed research. Applications that do not provide this information will be
returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a
description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In
addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in a NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance, No.
93.390. Awards are made under the authority of the Public Health Service
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158; 42
USC 241 and 285) and administered in accordance with the PHS Grants Policy
Statement and Federal regulations at 42 CFR Part 52 and 45 CFR Part 74. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.